FDA WARNING_LETTER - Columbia University Medical Center RDRC - May 17, 2011

The FDA issued a Warning Letter to Columbia University's Radioactive Drug Research Committee (RDRC) following a May 9-17, 2011 inspection, which found non-compliance with 21 CFR Part 361 governing radioactive drugs for human research. This inspection followed an April 7, 2010 clinical hold on all INDs and RDRC-approved studies using PET radioactive drugs from Kreitchman PET Center.

Key violations include: 1. **Failure to assure drug quality (21 CFR 361.1(d)(6)):** No documentation was provided for radionuclidic standards of identity/purity or sterility/pyrogen-free preparation of parenteral radioactive drugs. 2. **Failure to report adverse events (21 CFR 361.1(d)(8)):** Adverse events (e.g., headache, dizziness) observed in subject case report forms were not reported to the RDRC, and the RDRC lacked a mechanism for receiving such reports. The Chairman confirmed no adverse events had been reported since January 2007. 3. **Failure to review/approve research with a quorum (21 CFR 361.1(c)(2)):** Research was approved and commenced before full RDRC board review with a quorum. Additionally, a quorum was lost during a vote due to conflicts of interest, leading to approval without